Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.
Inclusion Criteria:
Diagnosis of newly diagnosed acute myeloid leukemia (AML).
Participant meets the following disease activity criteria:
Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Exclusion Criteria:
Fountain Valley, California 92708-7501, United States
Lexington, Kentucky 40536-7001, United States
New Orleans, Louisiana 70121, United States
Springfield, Missouri 65807-5287, United States
Greenville, South Carolina 29605-4255, United States
Dallas, Texas 75246-2003, United States
Edmonton, Alberta T6G 2B7, Canada
Toronto, Ontario M5G 2M9, Canada
Montreal, Quebec H4A 3J1, Canada
Wuhan, Hubei 430022, China
Xi’an, Shanxi 710038, China
Tianjin, Tianjin Municipality 300020, China
Hangzhou, Zhejiang 310003, China
Lübeck, Schleswig-Holstein 23538, Germany
Athens, 10676, Greece
RION Patras Achaia, 26504, Greece
Nyíregyháza, Szabolcs-Szatmár-Bereg 4400, Hungary
Bologna, Emilia-Romagna 40138, Italy
Milan, Milano 20122, Italy
Turin, Piedmont 10126, Italy
Ancona, 60126, Italy
Catania, 95123, Italy
Naples, 80131, Italy
Nagoya, Aichi-ken 453-8511, Japan
Yoshida-gun, Fukui 910-1104, Japan
Fukuoka, Fukuoka 811-1395, Japan
Higashi Ibaraki-gun, Ibaraki 311-3193, Japan
Osakasayama-shi, Osaka 589-8511, Japan
Hidaka-shi, Saitama 350-1298, Japan
Shinagawa-ku, Tokyo 141-8625, Japan
Nizhny Novgorod, Nizhny Novgorod Oblast 603126, Russia
Saint Petersburg, Sankt-Peterburg 197101, Russia
Busan, Busan Gwang Yeogsi 49241, South Korea
L'Hospitalet de Llobregat, Barcelona 08908, Spain
Taipei City, Taipei 100, Taiwan
Istanbul, 34098, Turkey (Türkiye)
London, Greater London E1 2ES, United Kingdom
London, Greater London NW1 2PG, United Kingdom
London, Greater London SE1 9RT, United Kingdom